Comparison of Antimicrobial Action of Sodium Hypochlorite and Polyhexamethylene Biguanide as Root Canal Irrigants

Phase 2

Completed

• Conditions: Irreversible Pulpitis
• Interventions: Drug: Sodium Hypochlorite; Drug: Polyhexamethylene biguanide

• Registration Number: NCT05306431
• Lead Sponsor: Altamash Institute of Dental Medicine

Brief Summary

The aim of this randomized clinical trial is to compare the antibacterial effects of sodium hypochlorite (NaOCl) and Polyhexamethylene biguanide during root canal treatment .

Detailed Description

This study will compare the antibacterial effectiveness of sodium hypochlorite and PHMB, to find out whether PHMB can be used as a substitute to NaOCL. Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant. It is non-corrosive, non-toxic and acts by disrupting cell membrane integrity.

Study Timeline

• Study First Submitted: 2022-03-19
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-01
• Study Start: 2022-06-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-11-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• • Patients aged 18 to 50 years

  • Both male and female patients
  • Periodontally healthy teeth as determined by Periodontal Probing
  • Patients with non-vital necrotic pulps as determined by Cold Test
  • Patients with acute apical periodontitis determined by history and clinical examination
  • Clinical Findings:

Visual: Carious tooth decay Occlusion: Hyperocclusion Pulp vitality test: Negative Periapical radiograph: Caries involving pulp space and PDL widening Percussion Test: Positive Palpation Test: Negative

• Single rooted teeth as determined radiographically

Exclusion Criteria

• • Multirooted teeth

  • Teeth undergoing Re-endo treatments
  • Teeth with root fractures and/ non restorable determined by clinical and radiographic examination
  • Patients receiving antibiotic treatment in the past 3 months determined by history
  • Patient with Diabetes determined by history
  • Patient with history of smoking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Hypochloride	Sodium Hypochlorite	A number of irrigant solution has thus been proposed to serve the purpose, the most popular being sodium hypochlorite (NaOCl) because of its excellent antimicrobial activity but also the ability to dissolve organic matter.
Polyhexamethylene biguanide	Polyhexamethylene biguanide	Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant. It is non-corrosive, non-toxic and acts by disrupting cell membrane integrity. PHMB 0.2% has been recently used as a root canal irrigant in vitro and has shown promising results of antimicrobial effectiveness of \> 99.9% for both PHMB and Sodium hypochlorite

Primary Outcome Measures

Name	Time	Method
Bacterial load assessed by culture	24 hours	Effectiveness of irrigant will be evaluated with the existence or non-existence of bacteria: Positive Effect = no bacteria exist, Negative Effect = bacteria exist. Bacterial analysis will be performed by counting the number of colonies of bacteria in the specimen: No growth = no colonies seen, Few growths = less than 10 colonies of bacteria seen, Moderate growth = less than 100 colonies more than 10 colonies of bacteria seen, Heavy growth = more than 100 colonies of bacteria seen.

Trial Locations

Locations (1)

Hira Danish; 🇵🇰 Karachi, Sindh, Pakistan